MedTrace Logo

The Angel® Catheter Pivotal Clinical Trial

NCT02186223 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2017-04-04

Study results available
· View outcomes & findings →

Summary

The primary objective of this multicenter, prospective, single arm clinical trial is to evaluate the safety and effectiveness of the Angel® Catheter in subjects at high risk of PE, and with recognized contraindications to standard pharmacological therapy (anticoagulation).

Conditions

Interventions

DEVICE

The Angel® Catheter

The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.

Sponsors & Collaborators

  • CardioMed Device Consultants, LLC

    collaborator INDUSTRY

  • Intrinsic Imaging, LLC

    collaborator UNKNOWN

  • Novella Clinical

    collaborator OTHER

  • BiO2 Medical

    lead INDUSTRY

Principal Investigators

  • Victor Tapson, MD · Cedars Sinai

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02186223 on ClinicalTrials.gov